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Research and Clinical Trials

Title  
COG AAML05P1: Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (HCT) for Refractory and Relapsed Acute Myelogenous Leukemia (AML) and Newly Diagnosed AML with Monosomy 7 or -5/5q- in Children
Brief Description  
This trial is studying donor stem cell transplant to see how well it works in treating young patients with newly diagnosed, relapsed, or refractory acute myeloid leukemia.
Who may be Eligible  

DISEASE CHARACTERISTICS:
  • Diagnosis of one of the following:
    • Primary refractory acute myeloid leukemia (AML) (> 5% bone marrow blasts after two cycles of induction chemotherapy)
    • Newly diagnosed AML with -5/5q- or monosomy 7 in patients who have completed two cycles of induction chemotherapy
    • Relapsed AML meeting the customary WHO criteria for AML
      • These patients must have undergone re-induction chemotherapy
  • No Fanconi anemia
  • No CNS disease
  • Up to 21 years of age
  • HIV negative
  • Not pregnant or nursing
  • Patients with proven or suspected bacterial sepsis, pneumonia, or meningitis are eligible provided appropriate therapeutic measures have been initiated to control the presumed or proven infection, and systemic signs are not life-threatening
  • No evidence or presence of a fungal infection within the past 30 days
  • Prior chemotherapy, radiotherapy or any antileukemic therapy allowed provided patients meet 1 of the following criteria:
    • Disease has failed induction chemotherapy on another primary treatment trial; these patients may have gone on to have additional therapy
    • Received initial treatment for relapsed AML
  • No treatment for fungal infection within the past 30 days
  • Concurrent radiotherapy to localized painful lesions allowed
  • No other concurrent cancer chemotherapy or immunomodulating agents
Speciality/Disorder  
Leukemia
IRB Number  
05-08-01A
Principal Investigator  
Kaplan, Joel

For More Information, Contact  Wendy  , Bissette
Phone:  (704) 355-9081  Fax:  (704) 355-1188  
Email:  Wendy.Bissette@carolinashealthcare.org
Address:1025 Morehead Medical Drive
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